Study of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

Exclusion Criteria

• •Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination).
• •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
• •Planned participation in another clinical trial during the present trial period
• •Self-reported or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• •Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection
• •Self-reported systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
• •Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
• •Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
• •Planned receipt of any vaccine in the 4 weeks following any trial vaccination
• •Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
• •Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures
• •Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator.